5 stories this morning, for surgeons and the people who support them.
- Smith+Nephew Q3 2026: revenue $1.551B (+3.4% underlying); US Knee Implants -7.3%, US Hip Implants -1.0%; FY26 underlying growth cut to ~3% from ~4%, trading profit to ~$1.25B from ~$1.3B, free cash flow to ~$750M from ~$800M; conversations with Johnson & Johnson over orthopaedics have ended and the board continues to explore options for Orthopaedics — Smith+Nephew's Nov 4 third-quarter trading update cut 2026 guidance on weaker US hips and knees and confirmed that discussions with Johnson & Johnson have ended, with its review of Orthopaedics continuing. Independently reported by ORTHOWORLD (https://www.orthoworld.com/smithnephews-sports-medicine-strength-offsets-u-s-joint-replacement-pressure/), which also supplied the cementless share and LANDMARK timing, and by AJ Bell/Alliance News (https://www.ajbell.co.uk/news/articles/smith-nephew-cuts-2026-outlook-talks-johnson-johnson-end). Zimmer Biomet US knees comparator: Q3 release (https://www.sec.gov/Archives/edgar/data/0001136869/000119312526446145/zbh-ex99_1.htm). Source
- FDA tells Anika the Hyalofast PMA is not approvable, primarily on the clinical data (FastTRACK missed its co-primary endpoints against microfracture); Vericel Q3 2026 MACI revenue $67.4M (+21%), FY26 MACI guidance raised to $290-292M from $284-290M — Anika's Nov 6 third-quarter release discloses an October FDA notice that the Hyalofast PMA is not approvable, primarily based on the clinical data, and cuts Commercial Channel growth guidance to 9-13% from 12-18%. Vericel's Nov 5 release (https://www.sec.gov/Archives/edgar/data/0000887359/000162828026070622/ex991earningsreleaseq32026.htm) reports MACI growth of 21% and raised guidance; ORTHOWORLD (https://www.orthoworld.com/vericels-maci-arthro-adoption-supports-sixth-straight-quarter-of-20-growth/) reports the arthroscopic share. FastTRACK topline: https://seekingalpha.com/pr/20182413-anika-reports-topline-results-from-u-s-pivotal-fasttrack-phase-iii-study-for-hyalofast. Agili-C code: ORTHOWORLD Smith+Nephew report above. Source
- FX Shoulder Solutions announces FDA 510(k) clearance of Easytech Reversed, which it describes as the first FDA-cleared stemless reverse shoulder system in the US; 90-patient, seven-site IDE study begun 2018 with follow-up completed 2023; no outcomes and no K number in the release — FX Shoulder Solutions announced the 510(k) clearance on Nov 5, and the first-in-US statement is the company's. Independently reported by ORTHOWORLD (https://www.orthoworld.com/fx-shoulder-solutions-earns-510k-for-easytech-reversed-system/) on Nov 6; the IDE enrollment was reported in 2022 (https://www.orthoworld.com/ide-study-update-fx-solutions-reversed-stemless-shoulder/). Source
- J Arthroplasty network meta-analysis of TKA alignment, 61 studies (22 RCTs), 7,822 patients: Forgotten Joint Score vs mechanical alignment +14.24 functional, +12.28 unrestricted kinematic, +8.75 restricted kinematic; only functional alignment exceeded the lower MCID, heterogeneity was high, unrestricted kinematic advantage 13.76 in observational studies vs 7.49 in RCTs; GRADE low to very low — A systematic review and network meta-analysis published online Nov 6 (doi 10.1016/j.arth.2026.11.002) found statistically better Forgotten Joint Scores with non-mechanical alignment strategies but concluded that clinically meaningful and certain superiority over mechanical alignment is not established. Peer-reviewed journal source; the show attributes the findings to the paper. Zimmer Biomet symposium listing (Nov 6, 'The Future Is Now — From Kinematic Alignment to Intelligent Surgery'): https://meddeviceguide.com/press-releases/zimmer-biomet-to-preview-the-next-era-of-intelligent-orthopedic-surgery-at-aahks-2026-20261029de82723 Source
- Am J Sports Med multicenter placebo-controlled RCT (NCT04440189, GID BIO): 114 patients with moderate-to-severe knee OA randomized to a single 25-million-cell autologous adipose SVF injection (n=83) or placebo (n=31); 12-month responder rate 51.8% vs 29% (difference 22.8%, 95% CI 3.5-42, one-sided P=.0149); no serious investigational device-related adverse events — A multicenter IDE trial published online Nov 5 (doi 10.1177/03635465261498163) reports a 12-month responder benefit for point-of-care adipose stromal vascular fraction against placebo. The ClinicalTrials.gov record (https://clinicaltrials.gov/study/NCT04440189) confirms GID BIO as sponsor and enrollment of 114; MRI was obtained but is not reported in the abstract. Source
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